"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
Oxtellar XR™ is indicated as adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
Administer Oxtellar XR™ as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals) [see CLINICAL PHARMACOLOGY]. If Oxtellar XR™ is taken with food, adverse reactions are more likely to occur because of increased peak levels [see CLINICAL PHARMACOLOGY].
Swallow Oxtellar XR™ tablets whole. Do not cut, crush, or chew the tablets. For ease of swallowing in pediatric patients or patients with difficulty swallowing, achieve daily dosages with multiples of appropriate lower strength tablets (e.g., 150 mg tablets).
Dosing for Adults in Adjunctive Therapy
The recommended daily dose of Oxtellar XR™ is 1,200 mg to 2,400 mg per day, given once daily. The dose of 2,400 mg per day showed slightly greater efficacy than 1,200 mg per day, but was associated with an increase in adverse reactions.
Initiate treatment at a dose of 600 mg per day given once daily for one week. Subsequent dose increases can be made at weekly intervals in 600 mg per day increments to achieve the recommended daily dose.
Dosing for Children (6 to 17 years of age) in Adjunctive Therapy
In pediatric patients 6 years to 17 years of age, initiate treatment at a daily dose of 8 mg/kg to 10 mg/kg once daily, not to exceed 600 mg per day in the first week.
Subsequent dose increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dose. The target maintenance dose, achieved over two to three weeks, is displayed in Table 1.
Table 1: Target Daily Dose in Pediatric Patients Aged 6 to 17 Years
|Weight||Target Daily Dose|
|20 kg to 29 kg||900 mg per day|
|29.1 kg to 39 kg||1200 mg per day|
|Greater than 39 kg||1800 mg per day|
Dosage Modifications in Patients with Renal Impairment
In patients with severe renal impairment (creatinine clearance less than 30 mL/minute), initiate Oxtellar XR™ at one-half the usual starting dose (300 mg per day). Subsequent dose increases can be made at weekly intervals in increments of 300 mg to 450 mg per day to achieve the desired clinical response. [see Use In Specific Populations].
Dosage Modifications in Geriatric Patients
In geriatric patients, consider starting at a lower dose (300 mg or 450 mg per day). Subsequent dose increases can be made at weekly intervals in increments of 300 mg to 450 mg per day to achieve the desired clinical effect [see Use In Specific Populations].
Dosage Modification for use with Concomitant Antiepileptic Drugs
Enzyme inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin decrease exposure to 10-monohydroxy derivative (MHD), the active metabolite. Dosage increases may be necessary. Consider initiating dose at 900 mg once per day [see DRUG INTERACTIONS].
Withdrawal of AEDs
Conversion from Immediate-Release Oxcarbazepine to Oxtellar XR™
In conversion of oxcarbazepine immediate-release to Oxtellar XR™, higher doses of Oxtellar XR™ may be necessary [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
150 mg: yellow modified-oval shaped with “150” printed on one side
300 mg: brown modified-oval shaped with “300” printed on one side
600 mg: brownish red modified-oval shaped with “600” printed on one side
Dosage Form Supplied
150 mg (yellow modified-oval shaped tablet printed “150” on one side with edible black ink).
Bottles of 100 tablets NDC 17772-121-01
300 mg (brown modified-oval shaped tablet printed “300” on one side with edible black ink).
Bottles of 100 tablets NDC 17772-122-01
600 mg (brownish red modified-oval shaped tablet printed “600” on one side with edible black ink).
Bottles of 100 tablets NDC 17772-123-01
Storage and Handling
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Oxtellar XR™ is manufactured by: Patheon Inc. Whitby, Ontario L1N 5Z5 CANADA. Distributed by: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA : October 2012
Last reviewed on RxList: 11/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Oxtellar XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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